Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms
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|ClinicalTrials.gov Identifier: NCT02543866|
Recruitment Status : Recruiting
First Posted : September 7, 2015
Last Update Posted : March 26, 2020
This protocol will evaluate fecal microbiota transplantation (FMT) as a strategy to eradicate intestinal colonization of extended-spectrum resistant (ESC-R) Enterobacteriaceae in pediatric patients.
FMT will be performed on subjects with a history of at least one infection due to ESC-R Enterobacteriaceae.
This protocol aims to determine the feasibility, safety, tolerability, and potential efficacy of FMT in pediatric patients with a history of ESC-R Enterobacteriaceae.
|Condition or disease||Intervention/treatment||Phase|
|Infection Resistant to Drugs||Biological: Fecal Microbiota Transplantation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Transplantation as a Strategy to Eradicate Intestinal Carriage of Resistant Organisms|
|Actual Study Start Date :||February 17, 2017|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2024|
Experimental: Fecal Microbiota Transplantation
Subjects will receive 50mL of prepared stool fecal via nasogastric tube
Biological: Fecal Microbiota Transplantation
Fecal Microbiota Transplantation
- Safety and Tolerability of FMT as measured by Incidence, severity, and relatedness of solicited, unsolicited, and serious adverse events [ Time Frame: 12 months post-FMT; optional long-tern follow-up for 5 years post-FMT ]Incidence, severity, and relatedness of solicited, unsolicited, and serious adverse events
- Efficacy of FMT [ Time Frame: 2 days, 2 weeks, 4 weeks, 8 weeks, 6 months, 12 months post-FMT ]Proportion of subjects free from ESC-R intestinal colonization and recurrent ESC-R infections 2 days, 2 weeks, 4 weeks, 8 weeks, 6 months, and 12 months post-FMT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543866
|Contact: Amanda Adlerfirstname.lastname@example.org|
|Principal Investigator:||Danielle Zerr, MD, MPH||Seattle Children's Hospital|